American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

February 11, 2025

Newsletter Sponsor

Get your Biologic Drug Product to Market Quickly and Safely
Sponsored by SGS
SGS Supports biopharmaceutical clients from discovery to clinical development and commercialization, through a comprehensive scope of expert-led quality control testing for raw materials, APIs, and finished products. Whether you need testing support through every stage of the drug development cycle or just when your in-house capabilities are limited, SGS serves as your trusted partner to support product characterization, method development and validation, bioanalysis and final GMP product release. View our biologics capabilities and resources to learn more!

	Industry News

PADCEV Plus KEYTRUDA® Shows Long-Term Efficacy in First-Line Treatment of Locally Advanced or Metastatic Urothelial Cancer
Pfizer Inc. and Astellas Pharma Inc. announced additional follow-up results from the Phase 3 EV-302 ... read more »

Oramed Forms Joint Venture to Accelerate Development and Commercialization of Oral Insulin
Oramed Pharmaceuticals Inc. will spin off its Protein Oral Delivery (POD™) technology into a newly ... read more »

Health Canada Approves KEYTRUDA® for Non-Small Cell Lung Carcinoma (NSCLC)
Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-... read more »

FDA Accepts NDA for Rare Neurodegenerative Disease
Biohaven Ltd. announced that the US Food and Drug Administration (FDA) has accepted for review the ... read more »

	QC Corner

The Future of Endotoxin Testing: USP Chapter 86 and the Shift to Recombinant Methods
This white paper covers an overview of USP Chapter <86>, the advantages of recombinant ... read more »

	Cell and Gene Therapy Circuit

Sensitive and Specific Detection of Mycoplasma DNA
This application note outlines a protocol designed to facilitate the preparation and detection of ... read more »

	Infographic

Pharmaceutical Sterility Testing
This infographic explores the drawbacks to traditional methods and the ways in which rapid testing methods are revolutionizing pharmaceutical ... read more »

	Featured Articles

		Navigating Global Expansion: Optimizing Local QPPVs And Regulatory Lifecycle Management for Mid-Size Pharma As mid-sized pharmaceutical companies expand globally, they face growing challenges. For example, the lack of global harmonization of post-approval ... read more »

		Real Time Analytics Implementation in Continuous Manufacturing Process monitoring and control support the maintenance of a state of control during production and allow real-time evaluation of system performance. ... read more »

	Featured Video

Cell and Gene Therapy Analytical Testing Considerations: Innovations from Thermo Fisher Scientific
Topics covered include key analytical testing considerations that are unique to cell and gene therapies, emerging analytical technologies that will ... watch »

Improve Your Microbial QC Testing Efficiency
Join us for an exciting webinar where we'll showcase how precisely quantitated MicroQuant™ products can revolutionize your microbial QC testing. Our ... watch »

	Featured Products

BioTrak® Real-Time Viable Particle Counter
TSI Incorporated Isolators are designed to keep operators out and sterile product safe. Nevertheless, traditional ... learn more »

BASF Virtual Pharma Assistants
BASF North America Save time and avoid costly missteps with the BASF Virtual Pharma Assistants, your interactive ... learn more »

	Featured Whitepaper

PyroCell® MAT Rapid Systems - Quick Start Guide
For over 30 years, Lonza has supported QC testing for endotoxins and pyrogens. Our portfolio now includes two PyroCell® MAT Rapid Systems with optimized reagents for sensitive pyrogen detection. ... read more »

eBook: QC in Cell & Gene Therapy: Ensuring Safety, Efficacy, and Consistency
This eBook is a guide for QC labs in cell and gene therapy to ensure safety, efficacy, and consistency. Topics covered include a look at the future of QC micro labs, addressing the QC challenges in ... read more »

	More Products

PyroWave™ XM Fluorescence Reader Learn More
Endosafe® Endochrome-K™ Kinetic Chromogenic (KCA) LAL Endotoxin Learn More
BacT/ALERT® 3D Microbial Detection System Learn More

	Directory Categories

Pharmaceutical Microbiology Search More

Endotoxin Detection and Testing Search More

Microbial Detection Systems Search More

	Events

4th mRNA Analytical Development & Quality Control Summit
Boston, Massachusetts – 02/25/2025
Excitement for mRNA therapeutics continues as RNA technologies are awarded the Nobel Prize for the second year running. Yet, despite optimized ... event details »

Bio-IT World Conference & Expo
Boston, Massachusetts – 04/02/2025
Bio-IT World Conference & Expo is the premier global event showcasing technologies and analytic approaches that solve problems, accelerate science, ... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
164 Townsend St. Unit 2
San Francisco, CA 94107 USA